Radiation Biodosimetry in Patients Treated With Total Body Irradiation (TBI)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00581958|
Recruitment Status : Active, not recruiting
First Posted : December 28, 2007
Last Update Posted : March 14, 2018
|Condition or disease||Intervention/treatment|
|Cancer||Other: Blood Samples|
|Study Type :||Observational|
|Actual Enrollment :||198 participants|
|Official Title:||Radiation Biodosimetry in Patients Treated With Total Body Irradiation (TBI)|
|Actual Study Start Date :||November 2007|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Patients undergoing HSCT
Research subjects will have blood and/or urine sampled at three time points in the Department of Radiation Oncology. Participating patients will have at least a total two samples collected at each time point. The first sampling will occur before the first TBI treatment is given. The second sampling will occur before the second TBI treatment, usually 3 to 8 hours after the first treatment (in the case of multifraction TBI). If a patient is being treated with single fraction TBI, then the second sampling will occur approximately 3-8 hours after the first TBI treatment. The third and final sampling will occur at the next morning blood draw, prior to the fourth TBI treatment (in the case of multifraction TBI), 24 hours after the first TBI treatment.
Other: Blood Samples
blood (approximately two 4 ml; equivalent to less than 2 tablespoon) and urine (a cup of urine) samples or testing a total of three times. Blood will be drawn and urine will be collected once before radiation treatment and twice after first radiation treatment.
- To develop, validate and refine high-throughput platforms for radiation biodosimetry using metabolomic assays. [ Time Frame: 3 years ]The approach involves profiling blood and urinary metabolites that are specific for radiation exposure and dose.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00581958
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Christopher Barker, MD||Memorial Sloan Kettering Cancer Center|